Declaration Of Conformity Of The Manufacturer - TECHNO-GAZ SLIM Notice D'utilisation Et D'entretien

TECNO-GAZ
9
The company:
TECNO-GAZ S.P.A. Strada Cavalli n. 4 - CAP 43038 - Sala Baganza – Parma – ITALY
Declares under its own responsibility that the Product (Medical lighting device for surgical and
diagnosis use):
made by TECNO-GAZ S.P.A., complies with Annex VII of Directive 93/42/EEC dated 14/05/1993,
and subsequent amendments (including Directive 2007/47/EC dated 05/09/2007) and the following
standards:
 IEC 60601-1
 IEC 60601-2-41
 IEC 60601-1-2
Classification with reference to article 9 and Annex IX of Directives 93/42/EEC and 2007/47/EC
DURATION:
DESCRIPTION:
CLASS I:
Name: Paolo Bertozzi
Position: Managing Director
Sala Baganza, 19-04-2012
Operation and
maintenance manual

Declaration of Conformity of the Manufacturer

(Part 1: General requirements for basic safety and essential performance)
(Part 1: Particular requirements for the safety of surgical luminaires and luminaires for
diagnosis)
(Part 2: General requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and tests)
Short term (Annex IX, Par.1 "Definitions", art.1, subsection 1.1)
Non-invasive medical device (Annex IX, Par.1 "Definitions", art.1, subsection 1.2)
Active medical device (Annex IX, Par.1 "Definitions", art.1, subsection 1.4)
(Annex IX, Par.3 "Classification", art.3, subsection 3.3, Rule 12) and
(Annex IX Par.3 "Classification", art.1, subsection 1.1 Rule 1)
MIU_023
Rev.1
PENTALED 12
APPLICARE
ETICHETTA
04/02/16
EN
Pag. 21 di 33